Clinical Trial: Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease
Brief Summary: Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase 2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD compared to control patients with a hazard ratio of 0.3. Based on these results the investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.
Detailed Summary:
Sponsor: moshe yeshurun
Current Primary Outcome: Proportion of patients with complete remission of acute GVHD [ Time Frame: 90 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of patients with partial remission of acute GVHD [ Time Frame: 90 days ]
- Proportion of patients with chronic GVHD [ Time Frame: 12 months ]
- Proportion of patients able to discontinue immunosuppression [ Time Frame: 12 months ]
- Transplant related mortality [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Rabin Medical Center
Dates:
Date Received: March 9, 2015
Date Started: April 2015
Date Completion:
Last Updated: March 18, 2015
Last Verified: March 2015
